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Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia (StimRAph)

Primary Purpose

Residual Aphasia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
atDCS
sham tDCS
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Residual Aphasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • right handedness
  • German native speaker
  • cerebrovascular stroke in left hemisphere (>6 months)
  • mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
  • residual anomia in naming test (>75 correct responses)

Exclusion Criteria:

  • other current or previous neurological or psychiatric diseases
  • alcohol or drug abuse
  • MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)

Sites / Locations

  • Charite, University Medicine, Dept. of NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

anodal tDCS

sham tDCS

Arm Description

atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex

sham tDCS will be administered to the left primary hand motor cortex

Outcomes

Primary Outcome Measures

Response latency during picture naming task (max. 80)
Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation. Order of stimulation will be counterbalanced across the group.

Secondary Outcome Measures

Change in neural activity measured by functional magnetic resonance imaging

Full Information

First Posted
April 30, 2013
Last Updated
April 30, 2013
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01845129
Brief Title
Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia
Acronym
StimRAph
Official Title
Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.
Detailed Description
Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Aphasia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS
Arm Type
Experimental
Arm Description
atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
sham tDCS will be administered to the left primary hand motor cortex
Intervention Type
Device
Intervention Name(s)
atDCS
Intervention Description
atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
Primary Outcome Measure Information:
Title
Response latency during picture naming task (max. 80)
Description
Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation. Order of stimulation will be counterbalanced across the group.
Time Frame
Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Secondary Outcome Measure Information:
Title
Change in neural activity measured by functional magnetic resonance imaging
Time Frame
Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: right handedness German native speaker cerebrovascular stroke in left hemisphere (>6 months) mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983) residual anomia in naming test (>75 correct responses) Exclusion Criteria: other current or previous neurological or psychiatric diseases alcohol or drug abuse MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Darkow, MSc
Phone
+49 30 450 560
Ext
395
Email
robert.darkow@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Meinzer, PhD
Organizational Affiliation
Charite, University Medicine, Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD
Organizational Affiliation
Charite, University Medicine, Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite, University Medicine, Dept. of Neurology
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Darkow, MSc
Phone
+49 30 450 560
Ext
395
Email
robert.darkow@charite.de
First Name & Middle Initial & Last Name & Degree
Marcus Meinzer, PhD
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD

12. IPD Sharing Statement

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Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia

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